Brii Biosciences released interim data from a phase 2/3 ACTIV-2 study, showing that the monoclonal antibody combination of BRII-196/BRII-198 reduced COVID-19 hospitalizations and death by 78% in high-risk patients, compared with placebo.
The study, sponsored by the National Institute of Allergy and Infectious Diseases, evaluated 837 patients enrolled within 10 days of COVID-19 symptom onset and at high risk for clinical progression and followed them for 28 days following treatment.
In the interim analysis of the ACTIV-2 trial, which was based on partial follow-up of the 837 participants, a reduction in both hospitalizations (12 active versus 45 placebo) and deaths (one active versus nine placebo) was observed.
BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect, the company said. Their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2.
